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New treatment option for Glioblastoma, IDH-Wildtype
Official title WP1066 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
ClinicalTrials.gov ID: NCT05879250
What this study is testing
What is STAT3 Inhibitor WP1066?
STAT3 Inhibitor WP1066 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for glioblastoma, idh-wildtype.
Also referred to as WP 1066, WP-1066.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial tests how well the combination of WP1066 and radiation therapy works in treating newly diagnosed glioblastoma. Glioblastoma is difficult to treat effectively because the cells within the tumor vary widely and are controlled by factors within and around the tumor, requiring multiple approaches to treat the tumor.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Newly diagnosed, histologically confirmed World Health Organization (WHO) glioblastoma multiforme (GBM), IDH wild-type
- External pathology reports are permitted for confirmation of histological diagnosis
- Documentation of isocitrate dehydrogenase (IDH) wild-type status will be by IDH1 R123H immunohistochemistry, except for patients =\< age 54 for whom...
- Documentation of O6-methylguanine-DNA methyltransferase (MGMT) unmethylated status per testing at any Clinical Laboratory Improvement Amendment...
- Cohort 1 only: Patients with prior gross total resection (GTR)
You likely can't join if
- Receipt of investigational agents within =\< 2 weeks prior to registration
- Prior receipt of gene therapy, at any time
- Prior receipt of bevacizumab, at any time
- Prior receipt of Gliadel, at any time
- Patients who are on active therapy with Optune and who are unable to safely discontinue Optune prior to initiating trial therapy Note: Patients who...
- Patients who are on active therapeutic anti-cancer therapy and who are unable to discontinue the anti-cancer therapy prior to initiating trial...
See the full eligibility criteria
Who can join
- Newly diagnosed, histologically confirmed World Health Organization (WHO) glioblastoma multiforme (GBM), IDH wild-type
- External pathology reports are permitted for confirmation of histological diagnosis
- Documentation of isocitrate dehydrogenase (IDH) wild-type status will be by IDH1 R123H immunohistochemistry, except for patients =\< age 54 for whom IDH sequencing will be required to detect noncanonical IDH mutations
- Documentation of O6-methylguanine-DNA methyltransferase (MGMT) unmethylated status per testing at any Clinical Laboratory Improvement Amendment (CLIA) certified laboratory
- Cohort 1 only: Patients with prior gross total resection (GTR)
- Cohort 2 only: Patients without prior gross total resection (GTR)
- Cohort 2 only: Measurable disease in the brain (per RANO criteria) on brain magnetic resonance imaging (MRI) scan conducted within =\< 4 weeks prior to initiating trial therapy
- Cohort 2 only: Patients who would benefit from non-emergent, palliative surgical resection, in the opinion of the local site's tumor board
- Able to initiate trial therapy within 8 weeks of the initial brain surgical procedure (biopsy or resection) that lead to the patient's initial diagnosis of GBM
- Age \>=18 years
- Karnofsky performance scale score \>= 60%
- White blood cell (WBC) count \>= 3.0 x 10\^9/L (within =\< 30 days prior to registration) (without growth factor support and/or receipt of blood products within =\< 14 days prior to testing)
- Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L (within =\< 30 days prior to registration) (without growth factor support and/or receipt of blood products within =\< 14 days prior to testing)
- Platelet count \>= 75 x 10\^9/L (within =\< 30 days prior to registration) (without growth factor support and/or receipt of blood products within =\< 14 days prior to testing)
- Total bilirubin =\ 1.5 x ULN (within =\< 30 days prior to registration)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =\< 2.5 x ULN (within =\< 30 days prior to registration)
- Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =\< 2.5 x ULN (within =\< 30 days prior to registration)
- Creatinine or creatinine clearance within normal institutional limits. A creatinine level above the institutional normal limit is acceptable, provided creatinine clearance (CrCl) is \>= 60 mL/min/1.73 m\^2 (within =\<...
- International normalized ratio (INR) =\< 1.5 x ULN or for people receiving anticoagulant therapy, INR must be within the therapeutic range of intended use of anticoagulants, as determined by the treating investigator...
- Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN or for people receiving anticoagulant therapy, aPTT must be within the therapeutic range of intended use of anticoagulants, as determined by the treating...
- Willing and able to tolerate brain MRI with contrast. Patients with any known severe allergy to contrast agent(s) should not participate in the study. Patients with mild allergies to contrast agents (e.g., rash only)...
- Willing and able to follow the below contraception requirements: For Females:
- Female people of childbearing potential (defined below) must agree to use adequate contraception (e.g., abstinence or 2 methods of birth control, such as a barrier method in combination with hormonal contraception)...
- Has not undergone a hysterectomy or bilateral oophorectomy
- Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months) For Males:
- Male people must agree to use adequate contraception (e.g., abstinence or 2 methods of birth control, such as a barrier method in combination with partner's use of hormonal contraception) starting from the time of...
- Subject (or subject's legally authorized representative if subject has impaired decision-making capacity) must have the ability to understand and the willingness to sign a written informed consent document
- Both men and women of all races and ethnic groups may participate in this trial
What rules you out
- Receipt of investigational agents within =\< 2 weeks prior to registration
- Prior receipt of gene therapy, at any time
- Prior receipt of bevacizumab, at any time
- Prior receipt of Gliadel, at any time
- Patients who are on active therapy with Optune and who are unable to safely discontinue Optune prior to initiating trial therapy Note: Patients who can safely discontinue Optune prior to initiating trial therapy may...
- Patients who are on active therapeutic anti-cancer therapy and who are unable to discontinue the anti-cancer therapy prior to initiating trial therapy Note: Patients who discontinue anti-cancer therapy prior to...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to WP1066 or its excipients
- Human immunodeficiency virus (HIV)-positive patients receiving combination antiretroviral therapy Note: These patients are ineligible because of the potential for pharmacokinetic interactions with WP1066. (HIV testing...
- Patients who have received drugs that significantly interact with CYP450 enzyme(s) within =\ 2 weeks prior to initiating treatment with WP1066 may participate. The enzymatic metabolism profile of WP1066 is unknown...
- Patients who have received any of the following agents within 7 days of planned first study treatment day:
- Agents that are predominantly CYP2D6, 2C9, or 2C19 substrates
- Agents that are strong inhibitors or inducers of CYP2D6, 2C9, or 2C19
- Agents that are sensitive substrates of CYP3A4 with narrow therapeutic range Note: Patients who are able to safely discontinue the aforementioned agents \> 7 days prior to initiating treatment with WP1066 may...
- Patients on corticosteroids who require escalation of the corticosteroid dose Note: Patients receiving a stable or decreasing dose for at least one week may participate. Zofran (ondansetron) is allowed
- History of brain hemorrhage, unless the following exception is met:
- Exception: Small, asymptomatic brain hemorrhage may be permitted, provided written documentation of PI approval has been obtained Note: The potential for further hemorrhaging with the use of WP1066 is unknown. It will...
- Uncontrolled seizures or seizure requiring escalation or addition of anti-epileptic drug
- Lesion(s) larger than 50 mm in maximal diameter on MRI, or with midline shift exceeding 5 mm, or with hydrocephalus
- Diffuse leptomeningeal disease Note: Because one of the objectives is PFS based on radiographic volumetric analysis of the tumor, the presence of diffuse leptomeningeal disease is excluded. This is secondary to the...
- Corrected QT (QTc) B interval \>= 450 ms These patients are excluded because the cardiac toxicities of WP1066 are unknown. Concomitant use of agents that prolong the QT interval should be avoided whenever feasible, or...
- people who are at increased risk for radiation therapy (RT)-associated toxicities, such as those with known active collagen vascular disease (e.g., scleroderma, Sjogren's disease, etc.) or other inherited...
- For female patients of childbearing potential only: Patients with a positive serum beta-human chorionic gonadotropin (HCG) pregnancy test within =\< 2 days prior to planned start date for trial therapy or who are...
- Breastfeeding patients who are unwilling/unable to discontinue breastfeeding while receiving WP1066 Note: Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of...
- Uncontrolled intercurrent illness or condition including, but not limited to any of the following: Ongoing or active infection requiring systemic treatment, except uncomplicated urinary tract infection;
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situation that would limit compliance with study requirements
- Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the subject's safety or study endpoints
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Warrenville, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Warrenville, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.